# P200022: Simplify® Cervical Artificial Disc

- Pathway: PMA
- Applicant: Nuvasive, Inc.
- Decided: Sep 18, 2020 after 177 days
- Product code: MJO (Prosthesis, Intervertebral Disc)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K211757: Simplify Disc (2021), 3 descendants of its own
- K220861: M6-C Artificial Cervical Disc Instruments AS (2022), 2 descendants of its own
- K241117: M6-C™ Single Use, Disposable Instrumentation (2024), 0 descendants of its own
- K231769: activL® Next Generation Instrumentation (2023), 0 descendants of its own

## Recalls of this device
- Jun 20, 2022 · Class II · Z-1453-2022: Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human r

Source page: https://510kreport.com/device/P200022
Methodology: https://510kreport.com/methodology